Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

FDA Letters Made Public Are Creating New Risks

There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

GUEST COLUMNISTS

Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
The Hidden Operational Cost Contained In Every Small Molecule Portfolio
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.
Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
How To Implement Post-Approval Changes On A Global Level
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.
March 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

PHARMA OUTSOURCING WHITE PAPERS

Quality By Design Understanding And Securing Virus Clearance
Data-driven virus clearance improves risk assessment, process insight, and study design. Learn how Quality by Design cuts late-stage risk while strengthening regulatory confidence and viral safety.

Advancing ADCs With Expertise In Payloads And Linkers
Discover how integrated containment, high-potency expertise, advanced chromatography, and proven linker–payload process optimization can accelerate your ADC program from early development to reliable commercial supply.
Early Discovery Of Functional Antibody Leads
Early functional screening accelerates therapeutic antibody discovery, improving hit rates and efficiency through advanced platforms like hybridoma upgrades, single B cell workflows, and tailored phage display strategies.
Tablet Manufacturing Technologies For Solid Drug Formulation
Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
mRNA Therapeutic Development Through Enhanced IVT Capping Efficiency
See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.
Considerations For Developing The Recirculation/Perfusion Process
Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.